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Bd Max Staphsr Assay, Instrument

by Geneohm Sciences Canada, Inc. (Bd Diagnostics)

510(k) K132822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132822 Date26 Nov 2013ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2333-2019 FDA Class II initiated 17 Jul 2019
    • Terminated Z-2332-2019 FDA Class II initiated 17 Jul 2019

    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NQX
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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